1. Field of the Invention
One or more embodiments of the invention are related to the field of infusion pump power management systems and battery charge alert systems. Specifically, one or more embodiments relate to a system and method of determining remaining battery capacity of an infusion pump and providing a message to a user before infusion begins, if a particular infusion will require a recharge based on the particular infusion to be performed and based on the current remaining battery capacity. At least one embodiment determines a required remaining duration of a programmed infusion of an infusion pump, an anticipated power capacity requirement to fully execute the programmed infusion, the remaining power capacity of batteries of the infusion pump, and whether the infusion pump will require a recharge prior to ambulation to avoid unexpected or premature therapy stoppage.
2. Description of the Related Art
Generally, ambulatory pumps are unique among infusion pumps in that patients on these pumps are anticipated to be somewhat mobile. In addition, ambulatory pumps, typically, may be used outside highly monitored clinical environments, such as in homes and alternate site locations. Generally, infusion systems rely on a combination of energy from main power sources and battery-powered sources to provide power for therapy delivery. Typically, during instances when power from a main power source is unavailable, such as during patient ambulation or during a grid-based power outage, the therapy delivery, such as infuser operation, is entirely dependent on a battery. These unique use cases provide challenges in managing the use of batteries incorporated within the infusion pump, as patients are typically not tethered to alternating current or “AC” power. In contrast, most hospital infusion pumps, such as syringe pumps or general IV/large volume pumps, are typically connected to AC power bedside and under most conditions remain plugged in, with exceptions being during patient transport and other short term events or lapses in plugging a pump back in following such an event. For example, hospital “pole-mounted” pumps typically use internal rechargeable batteries as a backup power source but are intended to be driven primarily by wall power. Ambulatory pumps, however, are generally used for long lengths of time, and potentially for entire infusion sessions, strictly on battery power. Ambulatory pumps have traditionally been designed around the use of disposable “drop-in” batteries, though the emergence of internal rechargeable batteries has been demonstrated in ambulatory pumps. Typically, the remaining charge within the battery ultimately determines the duration that therapy may continue without input from the main power source.
Infusion pumps are typically programmed without regard for the manner in which the pump will be powered throughout the specific infusion. For example, it may be anticipated that the pump will have sufficient power capacity available throughout AC power or internal batteries, and that overall power needs, low batteries, temporary or longer term lack of access to AC power, and other power management issues will be managed by the caregiver in a clinical environment, or by a patient or caregiver in a home or alternate site setting. In home infusion, a typical solution to ensure that sufficient battery life is available to complete an infusion, requires that new drop-in batteries are installed for each infusion, or every two infusions, per known battery capacities, therapy profiles, and intuition developed by the home infusion company over time. This has proven to be an expensive solution that leads to inefficient use of batteries since they are generally disposed of even when they still have remaining battery capacity. Also there is no link demonstrated between battery capacity and the required capacity to complete the programmed infusion.
The use of internal rechargeable batteries, generally, provides a solution to the economic challenges and practical implementation challenges of this previous practice, including the extreme case of trips to homes of patients to deliver new batteries. Introduction of a rechargeable battery into this use case introduces new practical challenges in that batteries may have unknown capacity prior to use, versus new “full” alkaline batteries, and that the ability to easily replace internal batteries may not be an option to the patient or caregiver. However, migration of the industry towards internal rechargeable batteries is inevitable, following the course of mobile electronic devices, such as laptop computers and cellular phones and the aforementioned benefits in total cost of use.
Generally, hospital infusion pumps utilize rechargeable internal batteries as backup batteries. These products all typically share details on battery capacity via % of remaining capacity, and often offer remaining battery capacity in only discrete values such as 25%, 50%, 75%, etc. Ambulatory pumps have been introduced that utilize disposable batteries as well as internal rechargeable batteries. These products also typically share details on battery capacity via % of remaining capacity. However, typical solutions generally do not relate remaining capacity to remaining infusion time. For example, remaining capacity is communicated only as a percentage of remaining charge and no translation of this metric to the remaining infusion time is provided or suggested. (Wearable pumps, such as insulin delivery pumps, are considered as a different category from ambulatory pumps as defined here and typically utilize disposable batteries and operate more or less continuously for the Type 1 diabetic patient.) Significant disadvantages of typical methods of communicating remaining battery capacity to users are that ambulatory pump users in a home may not be experienced and may not have yet have developed sophisticated intuition around remaining battery capacity and its link to remaining infusion time, which is typically dependent on infusion profile (rate and time) as well pump configurations (such as backlight or wireless communications settings). Known pumps will message or alarm “low battery” when operating on battery power and available battery capacity drops below a (often configurable) remaining infusion time, such as 30 minutes. However, such an alarm or message presents no forewarning and as such can leave the user in a position where they are unable to either change disposable batteries or access AC or other power sources to recharge internal batteries, a significant limitation to the ambulatory patient.
Generally, when the main power is lost or when a patient ambulates along with an infuser, the clinician may inquire only in a generally manner about the remaining battery charge. This is accomplished by observing an on-screen icon or another visual indicator, that typically displays an estimated fraction of the remaining battery capacity in a non-numeric graphical icon format. Nurses have generally reported that by not checking the battery charge remaining prior to ambulation has often resulted in stopping of therapy en route, as the required power consumption depletes the battery.
For example, U.S. Pat. No. 5,712,795 to Layman et al., entitled “Power Management System” discloses a power management system that appears to manage the power to operate a medical device internal battery to ensure the battery remains at full charge. The power management system of Layman et al., for example, may monitor the capacity of the battery and calculate the remaining charge of the battery based on charging activities and usage, and therefrom calculates the battery run time. However, the system appears to lack any teaching or suggestion of an infusion pump battery capacity management system that provides a notification or a warning to a user before infusion begins, that a particular infusion will require a recharge before or during therapy based on the current battery capacity. This system, as well as each of the other systems listed below, appears to lack any teaching or suggestion of an infusion pump battery capacity management system that provides a notification or a warning to a user during an infusion or following a change to the infusion that completion of the infusion will require a recharge.
U.S. Pat. No. 8,287,514 to Miller et al. entitled “Power Management Techniques For An Infusion Pump System” discloses various power management techniques that may avoid substantial power usage during operation of a pump system. The system of Miller et al. appears to use a pump system that may draw on energy supply to extend the life of the power supply and estimate the amount of power remaining to operate the pump system. However, the system appears to lack any teaching or suggestion of an infusion pump battery capacity management system that provides a notification or a warning to a user before infusion begins, that a particular infusion will require a recharge at some point based on the current battery capacity.
United States Patent Publication 20110162647 to Huby et al. entitled “Power Management In Respiratory Treatment Apparatus” discloses a respiratory apparatus that may provide treatment with a power management control, providing efficient power consumption to control the operations of various elements within the respiratory apparatus. For example, the system may control one or more elements of the apparatus to permit flow during peak power operation to minimize power drain of the power supply. In addition, the system appears to suggest estimating power needed for a typical sleep session for example based on stored historic treatment session information previously recorded. However, the system appears to lack any teaching or suggestion of an infusion pump battery capacity management system that provides a notification or a warning to a user before infusion begins, that a particular infusion will require a recharge based on the current battery capacity.
U.S. Pat. No. 5,814,015 to Gargano et al., entitled “Infusion Pump for at Least One Syringe”, discloses a processor driven syringe pump that operates in a rate, volume or amount per time, or pharmacokinetic mode by accepting input selections for a regimen and displaying operating conditions. The system of Gargano et al. appears to disclose a software program that provides a number of feedback warnings and alarms including battery status, remaining infusion time, etc. According to Gargano et al., the software also provides a continuous indication of remaining battery life on a display. However, the system of Gargano et al. appears to lack any teaching or suggestion of a battery charge alert system that provides a notification, alert or a warning to a user before infusion begins, of how long an active therapy will last on the battery power alone, for example during patient ambulation. In addition, the system of Gargano et al. appears to lack any teaching or suggestion of mitigating unexpected or premature stopping of therapy by a medical device when operating on battery power alone, for example through detection of potential ambulation events.
For example, U.S. Pat. No. 5,764,034 to Bowman et al. entitled “Battery Gauge For A Battery Operated Infusion Pump” discloses a system that may estimate the amount of time left on a battery by monitoring the voltage available and current flowing from the battery, and the amount of current flowing from the battery, to provide accurate battery monitoring during an ambulatory session for example. The system of Bowman et al. appears to disclose wherein the use of the auxiliary battery power raises the issue of monitoring of the available power in the battery at any given time. In addition, the system appears to provide a warning when battery voltage has decreased below a predetermined value. However, the system of Bowman et al. appears to lack any teaching or suggestion of mitigating unexpected or premature stopping of therapy by a medical device when operating on battery power alone, for example through detection of potential ambulation events. Furthermore, the system appears to lack any teaching or suggestion of an infusion pump battery capacity management system that provides a notification or a warning to a user before infusion begins, that a particular infusion will require a recharge at some point during the infusion based on the current battery capacity.
U.S. Pat. No. 5,321,392 to Skakoon et al. entitled “Infusion Pump With Battery Back-Up” discloses an infusion pump that may be powered via an AC line or via a battery, wherein a notification is provided when the pump detects that the battery has been depleted. However, the system appears to lack any teaching or suggestion of an infusion pump battery capacity management system that provides a notification or a warning to a user before infusion begins, that a particular infusion will require a recharge based on the current battery capacity.
For example, United States Patent Publication 20120226350 to Rudser et al. entitled “Controller and Power Source for Implantable Blood Pump” discloses a system for controlling the operation and power consumption of an implantable device, such that program information and modes of operation may be stored. For example, the system of Rudser et al. may generate a signal of the time remaining for operation under a current battery power, wherein such a time remaining may be displayed on a display device, such that when the time-remaining value reaches a threshold or range of values that may be dangerous to a patient, a warning is issued. However, the system appears to lack any teaching or suggestion of an infusion pump battery capacity management system that provides a notification or a warning to a user before infusion begins, that a particular infusion will require a recharge based on the current battery capacity.
World Intellectual Property Organization Publication 2011109774 to Bachman et al. entitled “Portable Controller With Integral Power Source For Mechanical Circulation Support Systems” discloses an external circulation support system with batteries and control electronics, such that the control and power sources may accommodate different patient configurations. The system of Bachman et al. appears to calculate time remaining on the power sources and track and store power drawn by components of the pump. However, the system appears to lack any teaching or suggestion of an infusion pump battery capacity management system that provides a notification or a warning to a user before infusion begins, that a particular infusion will require a recharge based on the current battery capacity.
U.S. Pat. No. 5,882,300 to Malinouskas et al., entitled “Wireless Patient Monitoring Apparatus Using Inductive Coupling”, discloses a wireless apparatus wherein a transducer detects a physiological function and provides an output signal thereof. According to the system of Malinouskas et al., battery current is sensed via a voltage divider for input to a battery monitoring circuit or gauge that keeps track of battery usage and charge currents. Compensation is made for diminished battery capacity due to age and self-discharge. In embodiments of the system of Malinouskas et al., LED indicators are illuminated for a brief time period after each detected motion, at the end of battery life, and when the transducer is placed into the charging station. Furthermore, according to Malinouskas et al., when the battery is near the end of its useful charge, at least one of the LED indicators will flash and a signal is transmitted to the fetal monitor console to notify the operator. However, the system of Malinouskas et al. appears to lack any teaching or suggestion of a battery charge alert system that provides a notification, alert or a warning to a user before infusion begins, of how long an active therapy will last on the battery power alone, for example during patient ambulation. In addition, the system of Malinouskas et al. appears to lack any teaching or suggestion of mitigating unexpected or premature stopping of therapy by a medical device when operating on battery power alone, for example through detection of potential ambulation events.
U.S. Pat. No. 8,792,981 to Yudovsky et al., entitled “Omnidirectional Accelerometer Device and Medical Device Incorporating Same”, discloses a portable medical device with an internal accelerometer that is configured to initiate acceleration-dependent operation of the portable medical device in response to generated signals present at the sensor signals. The system of Yudovsky et al. appears to disclose an alert module that detects alert conditions, alarm conditions, notification conditions, reminder conditions, and/or other conditions that trigger or otherwise prompt the medical device to generate corresponding alerts, alarms, notifications, reminders, flags, or the like. In embodiments of the device of Yudovsky et al., the conditions detected by the alert module may be associated with the operation, status, state, functionality, or characteristics of the medical device. According to Yudovsky et al., the alert module may cooperate with the accelerometer device, an accelerometer signal processing module, and an accelerometer response module to respond to detected physical activity and/or detected physical impacts. However, the system of Yudovsky et al. appears to lack any teaching or suggestion of a battery charge alert system that provides a notification, alert or a warning to a user before infusion begins, of how long an active therapy will last on the battery power alone, for example during patient ambulation.
For example, United States Publication 20120194341 to Peichel et al., entitled “Accelerometer Feedback Control Loop for Patient Alert”, discloses a system and method for delivering an alert signal to cause motion within a patient's body in response to detecting a condition. The system of Peichel et al. appears to disclose an accelerometer positioned to be sensitive to motion caused by delivering stimulation pulses to muscle tissue, wherein the accelerometer signal is received by a signal processing module and used by a controller in controlling an alert signal delivered to the patient in a closed-loop feedback method. According to Peichel et al., when an alert condition is detected, the system controls a patent alert signal using an accelerometer feedback signal, wherein such an alert may include expected battery life, battery replacement required, etc. However, the system of Peichel et al. appears to lack any teaching or suggestion of a battery charge alert system that provides a notification, alert or a warning to a user before infusion begins, of how long an active therapy will last on the battery power alone, for example during patient ambulation.
In summary, known system generally include calculating remaining battery life for a medical device, displaying warnings when the battery capacity is below a threshold and predicting remaining power. There are no known infusion pump battery management systems that provide a warning to a user before infusion begins, that a particular infusion will require a recharge, and pre-warn a user that a charge will be required based on a particular infusion to be performed and based on the current battery power level. In addition, there are no known systems that provide a user with options on proceeding with an infusion that enables the user to plan for recharging instead of reacting to a recharge warning or missing the warning altogether if they are unable to plan for a recharge. If a user falls asleep or is otherwise unconscious when a battery warning occurs, this may lead to deterioration in the user's medical condition. For at least the limitations described above there is a need for infusion pump battery capacity management system and method. In addition, in view of the above, there is a need for a system that alerts the nurse of remaining battery charge immediately prior to ambulation, via a vibratory, visual and/or audible alert. Additionally, there is a need for a system that provides estimates of the expected time duration that an active therapy will last on battery power alone, offering further insight into whether patient ambulation may be achieved without interrupting the infusion or therapy, to enable mitigating unexpected or premature stopping of therapy by a medical device when operating on battery power alone.